DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 6-16 and 25-27) in the reply filed on 06 February 2026 is acknowledged. The traversal is on the ground(s) that there would not be a serious burden for the examiner to search and examine all the claims together. This is not found persuasive because a burden has been established due to separate classifications as set forth in the restriction requirement per MPEP 808.02(A).
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06 February 2026.
Claims 6-16 and 25-27 are under current consideration.
Claim Objections
Claim 9 is objected to because of the following informalities: the phrase “is selected” in line 2 repeats. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7, 9-13, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bortz (US 2014/0364491 A1; published 11 December 2014).
Regarding claim 6, Bortz discloses an iron supplement (title) wherein companion composition is an orally deliverable composition comprising an agent for mitigating one or more gastrointestinal adverse effects of unabsorbed iron which may comprise a chelator component comprising an iron-chelating compound wherein any suitable controlled release mechanism may be employed such as enteric coatings well known to those of skill in the art (paragraph [0066]) wherein a chelating compound is formulated for delayed release such as in the jejunum, ileum, or colon (paragraphs [0039], [0050]) wherein a chelating compound may be deferiprone (paragraph [0069]) wherein the companion composition comprises chelating compound in a total amount of about 100-1000 mg per dosage unit of for example tablet or capsule (paragraph [0070]) wherein the companion composition optionally further comprises one of more excipients conventionally used in preparing pharmaceutical formulations such as diluents, binding agents, dispersants, wetting agents, lubricants, glidants, etc. (paragraph [0071]) wherein suitable wetting agents include glyceryl fatty acid esters such as glyceryl monostearate and glyceryl palmitostearate (paragraph [0061]) wherein suitable lubricants include glyceryl behenate and glyceryl palmitostearate and magnesium stearate (paragraph [0062]) wherein a discrete dosage form such as a tablet or capsule provides a full daily dose (paragraph [0038]) wherein an example companion tablet contains 500 mg DFO chelator and 250 mg excipients (i.e., 500/750 x 100wt% chelator and 250/750 x 100wt% excipients, or about 67 wt% chelator and about 33 wt% excipients) (Example 8; paragraph [0118]) wherein suitable glidants include colloidal silicon dioxide (paragraph [0063]).
Further regarding claim 6, although Bortz does not disclose a particular example as such, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bortz as discussed above and to make an oral tablet delayed release daily dose companion composition comprising about 100-1000 mg deferiprone chelating compound, glyceryl fatty acid ester wetting agent such as glyceryl monostearate or glyceryl palmitostearate (i.e., modifying release agents comprising glyceryl esters of long fatty acids), and lubricant such as glyceryl behenate or glyceryl palmitostearate (i.e., modifying release agents comprising glyceryl esters of long fatty acids), and having enteric coating, with a reasonable expectation of success.
Further regarding claim 6, the companion composition of Bortz includes about 100-1000 mg deferiprone in the tablet, with enteric coating thereon, which overlaps the claimed amount of about 1000 mg, and a prima facie case of obviousness exists where claimed ranges/amounts overlap disclosed ranges per MPEP 2144.05(I).
Further regarding claim 6, although Example 8 of Bortz discloses a tablet of about 67 wt% chelator rather than the claimed about 85-88 wt% deferiprone chelator, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize mitigation of gastrointestinal adverse effects of unabsorbed iron by varying the concentration of deferiprone chelator through routine experimentation per MPEP 2144.05(II) in the companion composition of Bortz as discussed above, with a reasonable expectation of success, given that Bortz teaches deferiprone as a chelator that mitigates gastrointestinal adverse effects of unabsorbed iron.
Further regarding claim 6, although Example 8 of Bortz discloses a tablet of about 33 wt% excipients rather than the claimed about 8-15 wt% modifying release agent comprising glyceryl esters of long fatty acids and about 0-2 wt% lubricant and/or glidant and about 0-5 wt% additional pharmaceutically acceptable excipients, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize wetting and/or lubrication in the companion composition of Bortz as discussed above by varying the concentration of glyceryl fatty acid esters such as glyceryl monostearate and/or glyceryl palmitostearate therein and/or varying the concentration of glyceryl behenate and/or glyceryl palmitostearate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Bortz teaches such compounds as suitable wetting agents and lubricants.
Regarding dependent claim 7, Bortz teaches glyceryl monostearate and glyceryl palmitostearate as discussed above regarding claim 6.
Regarding dependent claims 9-10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bortz as discussed above and to include magnesium stearate as a lubricant in the companion composition of Bortz as discussed above and to optimize lubrication in the companion composition of Bortz as discussed above by varying the concentration of magnesium stearate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Bortz teaches magnesium stearate as a suitable lubricant.
Regarding dependent claims 11-12, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bortz as discussed above and to include colloidal silicon dioxide as a glidant in the companion composition of Bortz as discussed above and to optimize glidant properties in the companion composition of Bortz as discussed above by varying the concentration of colloidal silicon dioxide therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Bortz teaches colloidal silicon dioxide as a suitable glidant.
Regarding dependent claim 13, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Bortz as discussed above and to include diluents (i.e., bulking agents) in the companion composition of Bortz as discussed above, with a reasonable expectation of success, given that Bortz teaches including diluents therein.
Regarding dependent claim 25, although Example 8 of Bortz discloses a tablet of about 33 wt% excipients rather than the claimed about 10 wt% modifying release agent comprising glyceryl esters of long fatty acids, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize wetting and/or lubrication in the companion composition of Bortz as discussed above by varying the concentration of glyceryl fatty acid esters such as glyceryl monostearate and/or glyceryl palmitostearate therein and/or varying the concentration of glyceryl behenate and/or glyceryl palmitostearate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Bortz teaches such compounds as suitable wetting agents and lubricants.
Regarding dependent claim 27, the claimed recitation of tablet release of less than about 20% of the deferiprone within 60 minutes when measured by USP Apparatus Type I basket method at 100 rpm in 900 mL at 37 °C and a pH of 4.5 or a pH of 6.8, such release property is presumed to be inherent in the composition of Bortz as discussed above per MPEP 2112(V) and 2112.01(I), given that the claimed composition and the composition of Bortz as discussed above are substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Claim(s) 6-13 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bortz as applied to claims 6-7, 9-13, 25, and 27 above, and further in view of Chang et al. (WO 2009/104838 A1; published 27 August 2009).
Bortz is relied upon as discussed above.
Bortz does not disclose glyceryl dibehenate as in dependent claims 8 and 26.
Regarding dependent claims 8 and 26, Chang et al. discloses sustained release solid formulations (title) wherein glyceryl fatty acid esters such as glyceryl palmitostearate and glyceryl behenate are used therein wherein glyceryl behenate under the trade name COMPRITOL 888 ATO is used therein as a lubricant and to control release (page 18 line 15 to page 19 line 7).
Further regarding dependent claims 8 and 26, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bortz and Chang et al. by using the COMPRITOL 888 ATO of Chang et al. as the glyceryl behenate and/or lubricant in the companion composition of Bortz as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include in the companion composition of Bortz a suitable lubricant and to better control release in the controlled release companion composition of Bortz and because Bortz teaches use of glyceryl fatty acid esters such as glyceryl behenate as well as use of lubricant in the companion composition of Bortz and because the selection of a known material based on its suitability for its intended use (i.e., known lubricant and release control excipient in solid formulations) supports a prima facie obviousness determination per MPEP 2144.07.
COMPRITOL 888 ATO is glyceryl dibehenate as acknowledged by applicant in the instant specification at paragraph [0094].
Claim(s) 6-7, 9-16, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bortz as applied to claims 6-7, 9-13, 25, and 27 above, and further in view of Chowhan et al. (US 6,224,911 B1; issued 01 May 2001).
Bortz is relied upon as discussed above.
Bortz does not disclose specific enteric coating as in dependent claims 14-16.
Regarding dependent claims 14-16, Chowhan et al. discloses enteric coated pharmaceutical dosage forms (title) wherein enteric coating comprises aqueous dispersion of 1:1 methacrylic acid and ethyl acrylate/methacrylate copolymers (claims 1-2) with plasticizers such as triethyl citrate or propylene glycol (column 3 lines 58-62) and with alcohol (column 3 lines 45-53).
Further regarding dependent claims 14-16, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bortz and Chowhan et al. by using the enteric coating of Chowhan et al. as discussed above as the enteric coating for the companion composition of Bortz as discussed above, wherein the enteric coating of Chowhan et al. comprises aqueous (i.e., water as diluent) dispersion of 1:1 methacrylic acid and ethyl acrylate/methacrylate copolymers (i.e., enteric polymer) with plasticizers such as triethyl citrate or propylene glycol and with alcohol (i.e., diluent), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so in order to provide for the companion composition of Bortz a suitable enteric coating because Bortz teaches to use enteric coatings known to those of skill in the art and Chowhan et al. teaches such enteric coatings known to those of skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-16 and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,016,850.
Although the claims at issue are not identical, they are not patentably distinct from each other because the concentrations of deferiprone and additional pharmaceutically acceptable excipients overlap, and overlapping amounts are prima facie obvious per MPEP 2144.05(I); and although the concentrations of modifying release agents are different, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize wetting and/or lubrication in the tablet of the ‘850 claims by varying the concentration of glyceryl fatty acid esters such as glyceryl monostearate, glyceryl palmitostearate, and/or glyceryl dibehenate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success; and although the ‘850 claims recite that the tablet is suitable for twice a day oral administration rather than once a day, such recitation does not imply/require any structural differences between the two; and regarding dependent claim 27 such recited release property is presumed to be inherent in the tablet of the ‘850 claims per MPEP 2112(V) and 2112.01(I), given that the claimed composition and the tablet of the ‘850 claims are substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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